Glaxosmithkline Biologicals SA v Sanofi Pasteur SA

There is a presumption in favour of staying parallel national patent proceedings pending opposition proceedings before the EPO, because a stay may avoid duplication and inconsistent outcomes. The presumption is not difficult to overcome. The court must weigh all relevant circumstances and decide where the interests of justice lie.

Relevant considerations include the likely duration of the EPO proceedings, the risk of amendments, commercial uncertainty, undertakings offered by the patentee, proportionality, delay, and the potential value of an early national judgment. A stay should be refused where the EPO proceedings are likely to take substantial time and the claimant would suffer significant practical or commercial prejudice from waiting.

GSK commenced proceedings seeking revocation of Sanofi’s UK designation of a European patent concerning pneumococcal vaccines. Sanofi applied for the action to be stayed pending the final determination of opposition proceedings before the EPO and its Boards of Appeal.

The parties accepted that parallel proceedings could create duplication and a risk of conflicting decisions. Sanofi relied on the presumption in favour of a stay and offered undertakings concerning infringement claims and the assessment of any damages. GSK relied on the likely delay in the EPO proceedings, the commercial uncertainty surrounding the proposed launch of its vaccine, and the benefit of an early UK decision.

The central issue was whether, having regard to all the circumstances, the interests of justice required the UK action to be stayed.

1. The stay application was dismissed. Sanofi was ordered to pay GSK’s costs, to be assessed.
2. Parallel national and EPO patent proceedings create an obvious risk of duplication and inconsistent outcomes. The authorities establish a presumption in favour of a stay, but the court must weigh the advantages of a stay against any injustice it would cause.
3. The relevant assessment is fact-sensitive. Factors favouring a stay included avoiding duplicated costs and the possibility that the EPO proceedings might revoke or amend the patent. The weight of those factors was reduced because the technical issues did not appear unduly complicated and Sanofi had already formulated auxiliary amendment requests which could also be advanced in the UK proceedings.
4. The likely duration of the EPO proceedings was important. Although an outcome by 2009 or 2010 was possible, there was a real and substantial risk of a considerably longer delay. If the opposition failed, further national proceedings might also be required.
5. GSK faced material commercial uncertainty if it launched its vaccine while the patent remained unresolved. Sanofi’s undertakings removed the risk of an injunction and limited potential damages, but they did not eliminate the uncertainty or provide GSK with the equivalent of a final determination of validity.
6. The court could also take into account the potential wider benefit of a prompt UK judgment in informing the parties’ efforts to resolve disputes in other jurisdictions. Proportionality, GSK’s earlier delay, and the fact that a UK decision would not determine the patent position throughout Europe were relevant but not decisive.
7. Balancing the factors, the early stage and uncertain duration of the EPO proceedings, the parties’ substantial commercial interests, and the importance of the proposed vaccine meant that justice would not be served by denying GSK the opportunity to pursue the action to an early conclusion.

The case was directed to be fixed for trial on a date not before 16 April 2007, with liberty to apply.